The Eustachian tube (ET) is an adnexa structure in the middle ear in man. It is a very narrow air passage in the wall of the middle ear which connects it to the nasopharynx, —a midline air filled space in the back of the nose. It is approximately 37 mm long and is slightly hour-glass shaped, flattened anterior-posteriorly. The small lumen of the eustachian tube permits the exchange of ambient gases between the middle ear and nasopharynx and the transport of middle ear secretions into the nasopharynx. The lateral one-third of the Eustachian tube (tympanic segment) is made of bone, while the medial two-thirds (pharyngeal segment) is cartilaginous. A constriction at the junction of the bony and cartilaginous segments, called the isthmus, may be as narrow as 1.0 mm by 1.5 mm. This tube regulates the intermittent exchange of air to or from the middle ear space to maintain equal pressure on both sides of the eardrum. The surface of the epithelium of the middle ear and eustachian tube is covered by a raucous blanket which is a defensive barrier against inhaled pollutants and a multitude of microorganisms. Middle ear secretions are normally eliminated through the ET.
In man, the Eustachian tube is a very unique structure that enables the middle ear pressure to adapt to various altitude changes and, and when closed it prevents the endogenous intraoral sounds of respiration and vocalization from reaching the middle ear to compete with and mask out the environmental sounds for reception and relay to the inner ear.
Normally, the Eustachian tube maintains an isobaric relationship between the middle ear space and the ambient air exchanged within the nasal passages during breathing. The critical opening pressure for the tube to ventilate the middle ear chamber is related to the surface tension and diameter of the ET opening onto the lateral wall of the nasopharynx. This is modified by the rheologic properties of the mucus blanket on the endothelial tissues. In its natural state, the Eustachian tube orifice is always closed, but may actively open spontaneously several times a minute or when swallowing or yawning. As integral part of the middle ear, the Eustachian tube functions to prevent and ameliorate the same inflammatory diseases such as otitis media etc. and its complications.
Incompetent Eustachian tube disorders refer to those conditions in which the closure of the facet at the orifice does not occur due to an increase in the diameter of the lumen of the Eustachian tube, a change in the surface tension of the secretions or fluid covering the mucous membrane, or a failure of the normal cartilage valve mechanism to passively relax for normal closure.
In this small sub set of individuals the Eustachian tube lumen is abnormally open continuously or intermittently. While the tube is open, it allows the respiratory sounds and speech of an individual to pass directly through the patent Eustachian tube to the middle ear sound-receiving mechanism. These individuals are very uncomfortable and frequently complain of a paradoxical symptom of a “clogged, plugged or stuffy ear” or a crackling or squeaking sound in actuality, there is a failure of the facet of Eustachian tube valve to passively collapse and seal the entrance at the nasopharynx. When they deny having a respiratory infection, further questioning may elicit a complaint of autophony (hearing their own breath sounds amplified in one's ear) and of hearing amphoric sounds in their ear similar to the sound of air being blown across the mouth of an uncapped empty bottle, or their voice sounding loud or strange. The symptom of autophony is pathognomonic of a patulous Eustachian tube disorder of the middle ear.
While the Eustachian Tube remains open, the continuous free flow of air from each respiration or vocal effort rushes to the middle ear causing the tympanum to resonate loudly. This uncontrollably amplifies the endogenous sounds (autophony) in one's ear. These forceful air currents, or acoustical energy, produced by breathing and vocalization generated within the approximate voice box, impact directly through the open Eustachian tube to the sensitive sound transmission system of the middle ear producing disturbing sounds and acoustical energy.
Unlike the symptoms of a common cold, PET symptoms totally disappear when lying down due to a shift of body fluids to the head increases local edema and passive closure of the tube. And so, to maintain closure, some patients spend the their day time hours supine, in bed.
The symptom of autophony—hearing the disturbing loud sounds from one's own breathing and voice, may be so disabling that many patients have considered suicide, and some attempts have been successful.
The patulous Eustachian tube syndrome and less severe variants such as a Patent, open, hyper-patent or semi-patulous Eustachian tube are variants of Eustachian tube incompetence.
In the past, different remedies have been recommended for the patulous Eustachian tube syndrome. These include sitting, and then bending over with ones head between the knees to increase nasal edema. Treatments included nasal insufflation of boric acid-salicylic acid power, local application of liquid silver nitrate, diathermy, Premarin hormonal or saturated solution of iodine (SSKI) drops. Another therapy has employed Kamikihi-To as reported by Jia-Wei-Gui-Pi-Tang. Some were impractical. None of these treatments have been consistently successful, nor are they without side effects, or serious complications.
In the inventor's previous related U.S. Pat. No. 5,470,587 (Nov. 28, 1995) which is herein incorporated by reference, the principle embodiment included hydrochloric acid (HCl), an inorganic acid. The invention sited above stimulated the necessary local edematous response to close the tube with the immediate, but short term, relief of symptoms due primarily to its pH effect. The properties of the novel invention and novel method of administration described herein stimulate both the immediate edema and the products essential for tissue healing, namely, dermatofibroblasts and pre-collagen fibers.
Surgical procedures have been advocated, including the injection of paraffin, Teflon, collagen, or Gelatin sponge injection into the wall around the Eustachian tube opening. Invasive surgery involving pterygoid hamulotomy has been performed or occlusion of the Eustachian tube lumen by a plug. Diathermy probe therapy has been used on the past. Laser-assisted endoscopic surgery or autologous fat grafting has been recommended for severely debilitating cases.
Additionally, among children in the US, 35 to 85 percent experience middle ear disease from otitis media in the first six months of life. Acute ear infections account for 15 to 30 million visits to the doctor each year in the U.S. In fact, ear infections are the most common reason why an American child sees the doctor. This is probably the result of prenatal deficiencies, and the infant or child's exposure to secondary smoke and respiratory viruses when their immune system is not fully developed.
Certain bacteria are reported to be the primary causes of acute otitis media (AOM) and are detected in about 60% of cases. The bacteria most commonly causing ear infections are: Streptococcus pneumoniae (also called S. pneumoniae or pneumococcus), the most common bacterial cause of acute otitis media, causing about 40% to 80% of cases in the U.S.; Haemophilus influenzae, the next most common culprit and is responsible for 20% to 30% of acute infections; and Moraxella catarrhalis, also a common infectious agent, responsible for 10% to 20% of Less common bacteria are Streptococcus pyogenes and Staphylococcus aureus. 
A serious sequalae of bacterial chronic otitis media includes otitis media with effusion (OME) which is associated with complications such as a ruptured tympanic membrane (TM). The failure of the Eustachian tube to expel or eliminate the natural secretions, microorganisms, biofilms and toxic products result in destruction of the tissues, TM rupture and hearing loss. When the fluid becomes infected the increased pressure is very painful and causes the delicate tympanic membrane to rupture releasing the toxins into the external ear canal for elimination
The ideal treatment should involve a product that is first safe and free of side effects, non-toxic, exhibit high potency at a pH that facilitates host tissue defenses while at the same level is detrimental to the reproductive cycle of most microorganisms, and the biochemical or physical property to break down the protective biofilm barrier surrounding the microorganism or toxins. It would be advantageous if embodiment has anti oxidant properties to reduce free radical toxins on the damaged host tissue and participate in the production of the essential ingredients (pre-collagen) to complete the healing process of the tissue and improved function.
In the past, antibiotics have been the mainstay of eliminating bacterial microorganisms by direct biochemical interaction. Antibiotics can only treat the infection when and if the agent is capable of penetrating the biofilm barrier and altering the biochemistry of the microorganism internally. This is seldom the case now.
Of note, about 15% of these bacteria are now believed to be resistant to the first-choice antibiotics. With the overuse of antibiotics and the development of resistance by microorganisms, such treatment has become less effective and frequent side effects have become common.
More recently, because the chemical structure of the newer anti-infective agents are more complex, antibiotics are not absorbable in the gastrointestinal tract, necessitating that the medication be administered by intravenous injection which is further associated with serious side effects such as ototoxicity, hearing loss and tinnitus, allergic reactions. Scientific studies have identified prenatal markers, such as smoking, that predispose the infant to develop middle ear infections. Among the prenatal risk factors for early Otitis Media (OM) that can be modified, mother's intake of vitamin C and alcohol during pregnancy could have future health implications. Alcohol may stimulate the fetal liver to produce metabolic enzymes which degrade vitamin C producing deficiencies in both the fetus and the infant. Vitamin C—deficient animals have neutrophils with reduced bactericidal activity and ascorbic acid may also play a role in the fetal development of cartilage, bone, and the muscle of the Eustachian tube.
Recent discoveries have identified a universal mechanism by which disease is transmitted, established, perpetuated and flourishes despite antibiotic therapy. This is through the protective covering of biofilm. The organic matter adheres to the surface target organ and shields the penetration of the external membrane of the microorganisms by many forms of chemotherapy. To be effective, it is necessary the therapeutic agent to break down the biofilm, and then inactivate the microorganisms by establishing a pH environment which is detrimental to their survival.
The relative acidity of a solution or tissue is measured according to a pH scale that ranges from 0-14. Those registering above 7 function within an alkaline environment, those below 7 are acidic. A solution with a pH of 7 is considered neutral. The mathematical symbol pH represents the logarithm of the reciprocal of the hydrogen-ion concentration in gram atoms per liter of solution. The level of the pH regulates the biochemical availability of nutrients for the chemical processes of all vital tissues to survive.
It is therefore desirable to provide a composition for the treatment of the fundamental pathologic processes antecedent to patulous Eustachian tube disorders and to the dysfunctional tubal stenosis in middle ear diseases by employing an effective, non-toxic composition with known co-enzymatic and vital tissue healing properties.